Ignite Creation Date:
2025-12-25 @ 5:08 AM
Ignite Modification Date:
2026-02-28 @ 10:35 PM
Study NCT ID:
NCT02993627
Status:
COMPLETED
Last Update Posted:
2019-04-11
First Post:
2016-11-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Spirulina Supplementation on Overweight or Obese Adults
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}, {'id': 'D001835', 'term': 'Body Weight'}], 'ancestors': [{'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004035', 'term': 'Diet Therapy'}, {'id': 'D004038', 'term': 'Diet, Reducing'}], 'ancestors': [{'id': 'D044623', 'term': 'Nutrition Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D004032', 'term': 'Diet'}, {'id': 'D009747', 'term': 'Nutritional Physiological Phenomena'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 52}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-04', 'completionDateStruct': {'date': '2017-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-04-10', 'studyFirstSubmitDate': '2016-11-27', 'studyFirstSubmitQcDate': '2016-12-13', 'lastUpdatePostDateStruct': {'date': '2019-04-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-12-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'body weight', 'timeFrame': 'week 12', 'description': 'body weight with minimum of clothes and without shoes through a calibrated scale and with the precision of 100gr'}, {'measure': 'BMI', 'timeFrame': 'week 12', 'description': 'calculation'}, {'measure': 'waist circumference', 'timeFrame': 'week 12', 'description': 'measuring with an inflexible tapeline with the precision of 0.1cm'}, {'measure': 'hip circumference', 'timeFrame': 'week 12', 'description': 'measuring with an inflexible tapeline with the precision of 0.1cm'}, {'measure': 'waist/hip ratio', 'timeFrame': 'week 12', 'description': 'calculation'}, {'measure': 'body fat mass', 'timeFrame': 'week 12', 'description': 'bioempedance'}, {'measure': 'body fat free mass', 'timeFrame': 'week 12', 'description': 'bioempedance'}, {'measure': 'apetite', 'timeFrame': 'week 12', 'description': 'questionaire'}], 'secondaryOutcomes': [{'measure': 'serum triaylglycerol', 'timeFrame': 'week 12', 'description': 'enzymatic method'}, {'measure': 'serum total cholesterol', 'timeFrame': 'week 12', 'description': 'enzymatic method'}, {'measure': 'e serum HDL-C', 'timeFrame': 'week 12', 'description': 'enzymatic method'}, {'measure': 'serum LDL-C', 'timeFrame': 'week 12', 'description': 'calculation'}, {'measure': 'serum LDL-C/HDL-C', 'timeFrame': 'week 12', 'description': 'calculation'}, {'measure': 'serum fasting glucose', 'timeFrame': 'week 12', 'description': 'enzymatic method'}, {'measure': 'serum insulin', 'timeFrame': 'week 12', 'description': 'enzymatic method'}, {'measure': 'HOMA-IR', 'timeFrame': 'week 12', 'description': 'calculation'}, {'measure': 'serum hs-CRP', 'timeFrame': 'week 12', 'description': 'eliza'}, {'measure': 'serum adiponectin', 'timeFrame': 'week 12', 'description': 'eliza'}, {'measure': 'serum SGOT', 'timeFrame': 'week12', 'description': 'enzymatic method'}, {'measure': 'serum SGPT', 'timeFrame': 'week 12', 'description': 'enzymatic method'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['obesity', 'BMI', 'body weight'], 'conditions': ['Obesity']}, 'referencesModule': {'availIpds': [{'id': '18039384', 'url': 'http://lipidworld.biomedcentral.com/articles/10.1186/1476-511X-6-33/', 'type': 'Clinical Study Report'}], 'references': [{'pmid': '18039384', 'type': 'RESULT', 'citation': 'Torres-Duran PV, Ferreira-Hermosillo A, Juarez-Oropeza MA. Antihyperlipemic and antihypertensive effects of Spirulina maxima in an open sample of Mexican population: a preliminary report. Lipids Health Dis. 2007 Nov 26;6:33. doi: 10.1186/1476-511X-6-33.'}, {'pmid': '18714150', 'type': 'RESULT', 'citation': 'Park HJ, Lee YJ, Ryu HK, Kim MH, Chung HW, Kim WY. A randomized double-blind, placebo-controlled study to establish the effects of spirulina in elderly Koreans. Ann Nutr Metab. 2008;52(4):322-8. doi: 10.1159/000151486. Epub 2008 Aug 19.'}, {'pmid': '12639401', 'type': 'RESULT', 'citation': 'Parikh P, Mani U, Iyer U. Role of Spirulina in the Control of Glycemia and Lipidemia in Type 2 Diabetes Mellitus. J Med Food. 2001 Winter;4(4):193-199. doi: 10.1089/10966200152744463.'}, {'pmid': '26813468', 'type': 'RESULT', 'citation': 'Miczke A, Szulinska M, Hansdorfer-Korzon R, Kregielska-Narozna M, Suliburska J, Walkowiak J, Bogdanski P. Effects of spirulina consumption on body weight, blood pressure, and endothelial function in overweight hypertensive Caucasians: a double-blind, placebo-controlled, randomized trial. Eur Rev Med Pharmacol Sci. 2016;20(1):150-6.'}, {'pmid': '25331487', 'type': 'RESULT', 'citation': 'Mazokopakis EE, Papadomanolaki MG, Fousteris AA, Kotsiris DA, Lampadakis IM, Ganotakis ES. The hepatoprotective and hypolipidemic effects of Spirulina (Arthrospira platensis) supplementation in a Cretan population with non-alcoholic fatty liver disease: a prospective pilot study. Ann Gastroenterol. 2014;27(4):387-394.'}, {'pmid': '20016733', 'type': 'RESULT', 'citation': 'Lee EH, Park JE, Choi YJ, Huh KB, Kim WY. A randomized study to establish the effects of spirulina in type 2 diabetes mellitus patients. Nutr Res Pract. 2008 Winter;2(4):295-300. doi: 10.4162/nrp.2008.2.4.295. Epub 2008 Dec 31.'}]}, 'descriptionModule': {'briefSummary': 'In this double-blind Randomized Controlled Clinical Trial investigators are going to study the effects of Spirulina supplementation on anthropometric measurements, lipid profile, appetite, liver enzymes, inflammatory and glycemic markers in a sample of overweight or obese adults.', 'detailedDescription': 'A sample of 40 obese and overweight subjects will be recruited from Nutrition And Diet Therapy Clinic Of Shahid Beheshti Medical University.\n\nThis study is a double-blind Randomized Controlled Clinical Trial, that subjects will be randomly allocated to spirulina or placebo group according to the Random permuted blocks within strata method based on BMI. Subjects will consume 2 g spirulina daily (4 tablets of 500mg), whereas the control group are going to receive identical placebo tablets. Subjects are asked to maintain their usual physical activity level during the intervention period and also avoid taking any other supplements or medications without consulting the investigators. Intervention period is designed to be 12 weeks that has been determined sufficient to record changes of study parameters. At the beginning of the study and after 12 weeks of intervention, morning blood samples will be collected after 12 h of fasting. Anthropometric parameters will be also measured at the beginning, week 6 and after 12 weeks of intervention. Subjects will be followed through social network to ensure their compliance with the study. Furthermore, subjects in both spirulina and placebo groups received low calorie diet (-500 or -300 kcal) composed of 55% carbohydrate, 15% protein and 30% fat during the study period.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* BMI\\>25 kg/m2\n* No history of medications for obesity, diabetes, dyslipidemia, inflammatory disease within 3 months before the study\n* No history of vitamin or antioxidant supplementation within 3 months before the study\n* Giving written informed consent for participation\n\nExclusion Criteria:\n\n* Having chronic kidney or hepatic disease except NAFLD\n* Havig hypo or hyperthyroidism\n* Having autoimmune and infectious disease\n* weight reduction diet therapy within 6 month from the intervention\n* Having more than 3kg weight change in recent 2 months\n* Having recent surgery\n* Taking anticoagulant drugs'}, 'identificationModule': {'nctId': 'NCT02993627', 'briefTitle': 'Effects of Spirulina Supplementation on Overweight or Obese Adults', 'organization': {'class': 'OTHER', 'fullName': 'Shahid Beheshti University of Medical Sciences'}, 'officialTitle': 'Effects of Spirulina Supplementation on Anthropometric Measurements, Lipid Profile, Appetite, Liver Enzymes, Inflammatory and Glycemic Markers on Overweight or Obese Adults', 'orgStudyIdInfo': {'id': 'IR.SBMU.nnftri.Rec.1395.63'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Spirulina', 'description': 'daily intake of spirulina tablets weight reduction diet therapy', 'interventionNames': ['Dietary Supplement: Spirulina', 'Other: diet therapy']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'placebo', 'description': 'daily intake of placebo tablets weight reduction diet therapy', 'interventionNames': ['Other: diet therapy']}], 'interventions': [{'name': 'Spirulina', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['Spiruvit'], 'description': '2 g(4\\* 500 mg tablets) daily intake of Spirulina Platensis', 'armGroupLabels': ['Spirulina']}, {'name': 'diet therapy', 'type': 'OTHER', 'otherNames': ['weight reduction diet'], 'description': 'low calorie diet (-500 or -300 kcal) composed of 55% carbohydrate, 15% protein and 30% fat', 'armGroupLabels': ['Spirulina', 'placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1981619573', 'city': 'Tehran', 'country': 'Iran', 'facility': 'Clinical Nutrition and Diet Therapy Clinic of Shahid Beheshti University of Medical Sciences', 'geoPoint': {'lat': 35.69439, 'lon': 51.42151}}], 'overallOfficials': [{'name': 'Atoosa Saidpour', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Shahid Beheshti University of Medical Sciences'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shahid Beheshti University of Medical Sciences', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor of Nutrition Science', 'investigatorFullName': 'Atoosa Saidpour', 'investigatorAffiliation': 'Shahid Beheshti University of Medical Sciences'}}}}